Definition: Embolic Protection For Transcatheter Intracardiac Procedures
| Device Type ID | 985 |
| Device Name | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Physical State | This Device Is A Single Use Percutaneous Catheter System That Has (a) Blood Filter(s) At The Distal End And Is Introduced Into An Artery Through The Skin Using A Guidewire. |
| Technical Method | This Device Is A Single Use Percutaneous Catheter System That Is Introduced Into An Artery. |
| Target Area | Aortic Arch Or Aortic Arch Branch Vessels. |
| Regulation Description | Temporary Catheter For Embolic Protection During Transcatheter Intracardiac Procedures. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1251 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 985 |
| Device | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Product Code | PUM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Temporary Catheter For Embolic Protection During Transcatheter Intracardiac Procedures. |
| CFR Regulation Number | 870.1251 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CLARET MEDICAL, INC. | ||
GRANTED | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 9 |
Difficult To Remove | 4 |
Material Integrity Problem | 3 |
Difficult Or Delayed Positioning | 2 |
Contamination / Decontamination Problem | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Positioning Failure | 1 |
Material Separation | 1 |
Collapse | 1 |
Packaging Problem | 1 |
| Total Device Problems | 25 |